Pacira BioSciences.
Senior Director, Translational Science
Pacira BioSciences., San Diego, California, United States, 92189
About Pacira
Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.u00A0u00A0u00A0u00A0u00A0 u00A0u00A0u00A0
Why work with us?
Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.u00A0 At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, letu2019s pursue excellence together.u00A0u00A0
Summary:The Senior Director, Translational Science leads translational and nonclinical development activities in support of candidate selection, clinical development, and product registration of Pacira portfolio programs.
The Senior Director, Translational Science is responsible for the design, conduct, analysis, and reporting of pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker development and analysis validation, biodistribution studies, and leads the strategic plan for these studies.
This position interacts with internal and external stakeholders, including regulatory authorities to ensure appropriate communication of all translational science study strategy, results, and conclusions.
u00A0
Essential Duties & Responsibilities
:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned. u00A0 The Senior Director of Translational Science will drive all aspects of the translational strategy, including pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker development and biodistribution studies, and will be accountable for delivering key translational milestones from candidate selection to product registration. Scientific Leadership and Communication
Establish and execute the strategic direction and design of the companyu2019s translational safety and pharmacology plans, with a deep understanding of cell and gene therapy platformsIdentify significant issues and risks that may impact overall project plans and initiate contingency plans as appropriateEnsure appropriate scientific rigor and regulatory compliance in the design, conduct, validity, and interpretation of non-clinical data to support clinical programs and regulatory applicationsProvide scientific oversight and CRO management for translational IND enabling studies, including exploratory and GLP PK/TK studies, PD and biomarker development and analysis validation, biodistribution studies, and development of assays for Anti-Drug Antibody (ADA) assessmentEstablish PK/PD endpoints for appropriate sampling of clinical protocols, development of molecular assays and advancement of phase appropriate programsResponsible for the strategic planning, authoring, and review of the translational biology components of regulatory documents, scientific data, and publicationsu00A0Contribute to scientific and clinical interface with key opinion leaders (KOL), facilitating KOL advocacy developmentRepresent Translational Science when presenting to project and corporate governance meetingsCollaborate and Mentor
Lead the Translational Science function, while collaborating with internal and external teams to progress the understanding of the biology behind clinical trials and PK/PD data as necessaryIdentify and collaborate with academic investigators to optimize the translational strategy and plans for programsEngage with clinical development teams to inform execution of translational sciences programs including development and validation of product specific clinical assaysu00A0Lead or participate in cross-functional working groups such as scientific and safety review boardsMentor and develop an interdisciplinary development team, fostering a culture of innovation and scientific rigor in a highly matrixed work environmentManage CROs and scientists that will be interfacing with Research and Development groups as new therapies are advancedContribute to departmental resource planning, budgeting and timeline setting to meet company needsSupervisory Responsibilities:
This position may have supervisory responsibilities.
u00A0
Interaction:
The incumbent works closely with internal teams and vendors. u00A0
Education and Experience:
A PhD degree with a minimum of 10 years of, or a masteru2019s degree with a minimum of 15 years of, combined academic and biotechnology or pharmaceutical experience in Non-clinical Research, and/or Translational Sciences, including experience in genetic medicine, immunology, inflammation, and/or pain researchPrior experience in translational science with in-depth knowledge of PK, TK, and PD principles, biomarker development, and biodistribution studies, as well as a significant publication track record supporting this experienceQualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily and work independently, planning their time to meet both short-term and long-term objectives. The requirements described above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. u00A0
Knowledge, Skills, and Abilities
:
Deep understanding of and direct experience in immunology, inflammation, and/or pain pharmacology, in both early and late stages of developmentu00A0Demonstrated ability to integrate scientific rationale, target biology, clinical strategy, and target product profile to develop appropriate translational strategiesu00A0Strong understanding of the regulatory requirements for translational research and drug developmentAbility to effectively present ideas and document complex medical/clinical concepts in both written and oral communication for internal and external useOutstanding communication skills with the ability to effectively converse with a variety of audiences including team members, cross-functional project teams, project leaders, KOLs and senior managementGeneral familiarity with biostatistics and/or pharmacometrics; expert in navigating scientific literature, interpretation of data, display of dataExcellent interpersonal relationship and people skillsDemonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in a fast paced, innovative and performance driven environmentAttention to detail, experience in monitoring work to assure quality, accuracy, and thoroughnessComfortable challenging the status quo and bringing forward innovative solutions to make better possibleStrong commitment to ethical standardsAbility to travel up to 20%u00A0u00A0
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
u00A0 While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse. Will need to lift and move items weighing up to 40 pounds. u00A0
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.u00A0 u00A0 The work setting is consistent of a typical pharmaceutical office environment with production areas, offices, and cubicles.
Benefits:
u00A0u00A0u00A0u00A0u00A0
Medical, Prescription, Dental, Vision CoverageFlexible Spending Account & Health Savings Account with Company matchEmployee Assistance ProgramMental Health ResourcesDisability CoverageLife insuranceCritical Illness and Accident InsuranceLegal and Identity Theft ProtectionPet InsuranceFertility and Maternity Assistance401(k) with company matchFlexible Time Off (FTO) and 11 paid holidaysPaid Parental Leave
#J-18808-Ljbffr
Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.u00A0u00A0u00A0u00A0u00A0 u00A0u00A0u00A0
Why work with us?
Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.u00A0 At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, letu2019s pursue excellence together.u00A0u00A0
Summary:The Senior Director, Translational Science leads translational and nonclinical development activities in support of candidate selection, clinical development, and product registration of Pacira portfolio programs.
The Senior Director, Translational Science is responsible for the design, conduct, analysis, and reporting of pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker development and analysis validation, biodistribution studies, and leads the strategic plan for these studies.
This position interacts with internal and external stakeholders, including regulatory authorities to ensure appropriate communication of all translational science study strategy, results, and conclusions.
u00A0
Essential Duties & Responsibilities
:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned. u00A0 The Senior Director of Translational Science will drive all aspects of the translational strategy, including pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker development and biodistribution studies, and will be accountable for delivering key translational milestones from candidate selection to product registration. Scientific Leadership and Communication
Establish and execute the strategic direction and design of the companyu2019s translational safety and pharmacology plans, with a deep understanding of cell and gene therapy platformsIdentify significant issues and risks that may impact overall project plans and initiate contingency plans as appropriateEnsure appropriate scientific rigor and regulatory compliance in the design, conduct, validity, and interpretation of non-clinical data to support clinical programs and regulatory applicationsProvide scientific oversight and CRO management for translational IND enabling studies, including exploratory and GLP PK/TK studies, PD and biomarker development and analysis validation, biodistribution studies, and development of assays for Anti-Drug Antibody (ADA) assessmentEstablish PK/PD endpoints for appropriate sampling of clinical protocols, development of molecular assays and advancement of phase appropriate programsResponsible for the strategic planning, authoring, and review of the translational biology components of regulatory documents, scientific data, and publicationsu00A0Contribute to scientific and clinical interface with key opinion leaders (KOL), facilitating KOL advocacy developmentRepresent Translational Science when presenting to project and corporate governance meetingsCollaborate and Mentor
Lead the Translational Science function, while collaborating with internal and external teams to progress the understanding of the biology behind clinical trials and PK/PD data as necessaryIdentify and collaborate with academic investigators to optimize the translational strategy and plans for programsEngage with clinical development teams to inform execution of translational sciences programs including development and validation of product specific clinical assaysu00A0Lead or participate in cross-functional working groups such as scientific and safety review boardsMentor and develop an interdisciplinary development team, fostering a culture of innovation and scientific rigor in a highly matrixed work environmentManage CROs and scientists that will be interfacing with Research and Development groups as new therapies are advancedContribute to departmental resource planning, budgeting and timeline setting to meet company needsSupervisory Responsibilities:
This position may have supervisory responsibilities.
u00A0
Interaction:
The incumbent works closely with internal teams and vendors. u00A0
Education and Experience:
A PhD degree with a minimum of 10 years of, or a masteru2019s degree with a minimum of 15 years of, combined academic and biotechnology or pharmaceutical experience in Non-clinical Research, and/or Translational Sciences, including experience in genetic medicine, immunology, inflammation, and/or pain researchPrior experience in translational science with in-depth knowledge of PK, TK, and PD principles, biomarker development, and biodistribution studies, as well as a significant publication track record supporting this experienceQualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily and work independently, planning their time to meet both short-term and long-term objectives. The requirements described above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. u00A0
Knowledge, Skills, and Abilities
:
Deep understanding of and direct experience in immunology, inflammation, and/or pain pharmacology, in both early and late stages of developmentu00A0Demonstrated ability to integrate scientific rationale, target biology, clinical strategy, and target product profile to develop appropriate translational strategiesu00A0Strong understanding of the regulatory requirements for translational research and drug developmentAbility to effectively present ideas and document complex medical/clinical concepts in both written and oral communication for internal and external useOutstanding communication skills with the ability to effectively converse with a variety of audiences including team members, cross-functional project teams, project leaders, KOLs and senior managementGeneral familiarity with biostatistics and/or pharmacometrics; expert in navigating scientific literature, interpretation of data, display of dataExcellent interpersonal relationship and people skillsDemonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in a fast paced, innovative and performance driven environmentAttention to detail, experience in monitoring work to assure quality, accuracy, and thoroughnessComfortable challenging the status quo and bringing forward innovative solutions to make better possibleStrong commitment to ethical standardsAbility to travel up to 20%u00A0u00A0
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
u00A0 While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse. Will need to lift and move items weighing up to 40 pounds. u00A0
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.u00A0 u00A0 The work setting is consistent of a typical pharmaceutical office environment with production areas, offices, and cubicles.
Benefits:
u00A0u00A0u00A0u00A0u00A0
Medical, Prescription, Dental, Vision CoverageFlexible Spending Account & Health Savings Account with Company matchEmployee Assistance ProgramMental Health ResourcesDisability CoverageLife insuranceCritical Illness and Accident InsuranceLegal and Identity Theft ProtectionPet InsuranceFertility and Maternity Assistance401(k) with company matchFlexible Time Off (FTO) and 11 paid holidaysPaid Parental Leave
#J-18808-Ljbffr